NCT04477187

Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

Completed NA Results posted Last updated 19 December 2023

What this trial tests

NA trial testing Dermal Handpiece in Skin Laxity in 15 participants. Completed in 22 December 2022.

Timeline

1 October 2020

Primary endpoint
13 June 2022

22 December 2022

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 October 2020
Primary completion	13 June 2022
Estimated completion	22 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Dermal Handpiece

Conditions studied

• Skin Laxity — all drugs for Skin Laxity →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 21 to 70, any sex, with Skin Laxity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline of Soft Tissue Surface Area Primary · Month 3 and Month 6 Follow Up

3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

Group	Value	95% CI
Month 3 Follow Up	-0.18	± 0.89
6 Month Follow Up	-017	± 0.32

Percent Change From Baseline in Volume Primary · Month 3 and Month 6 Follow Up

3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

Group	Value	95% CI
Month 3 Follow Up	-1.30	± 0.68
6 Month Follow Up	-1.9	± 1.8

Percent Change in Minor Tissue Strain Primary · Month 3 and Month 6 Follow Up

Percent change in Minor Tissue Strain is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

Group	Value	95% CI
Month 3 Follow Up	-5.0	± 2.5
6 Month Follow Up	-0.44	± 0.53

Percent Change in Horizontal Displacement Primary · Month 3 and Month 6 Follow Up

Percent change in Horizontal Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

Group	Value	95% CI
Month 3 Follow Up	-0.55	± 0.99
6 Month Follow Up	-0.44	± 0.53

Percent Change in Vertical Displacement Primary · Month 3 and Month 6 Follow Up

Percent change in Vertical Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

Group	Value	95% CI
Month 3 Follow Up	0.04	± 1.06
6 Month Follow Up	-0.19	± 0.81

Improvement in Assessments: Global Aesthetic Improvement Score Secondary · Baseline - 6 Months (Day 180)

Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)

Group	Value	95% CI
Blinded Assessment	2.727	± 0.49

Subjects Assessment of Pain: Numerical Pain Rating Scale Secondary · Visit 2 (Day 0- immediately after study procedure)

Immediately after the study procedure, subjects will be asked to rate any pain or discomfort using a 11-point Numerical Pain Rating Scale (0= No pain, 10= Extreme pain)

Group	Value	95% CI
Single Group	1.96	0.80 – 3.11

Non-invasive Measurements: Transepidermal Water Loss Measurements Secondary · Baseline, 3 Month and 6 Month Follow Up

Skin texture and laxity will be assessed using non invasive skin measurements. Biox Aquaflux- will be used to measure transepidermal water loss.

Group	Value	95% CI
Baseline	14.084	± 3.821
Month 3 Follow Up	11.095	± 4.539
6 Month Follow Up	14.246	± 6.661

Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz] Secondary · Baseline, 3 months, 6 Months (Day 180)

Skin texture and laxity will be assessed using non invasive skin measurements. Skin laxity and elasticity are measured using the Biomechanical Tissue Characterization System. Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin. Ra, is the average measurement of skin curvatures and takes into all account variances in the skin roughness profile from the center line. Rz, is the difference between the highest and lowest data points from the mean surface measurement.

Ra (arithmetic mean roughness)

Group	Value	95% CI
Baseline	0.015	± 0.004
Month 3 Follow Up	0.014	± 0.004
6 Month Follow Up	0.014	± 0.005

Rz (Average depth of roughness)

Group	Value	95% CI
Baseline	0.105	± 0.027
Month 3 Follow Up	0.1	± 0.028
6 Month Follow Up	0.095	± 0.028

Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient Secondary · Baseline, 3 months, 6 Months (Day 180)

Skin texture and laxity will be assessed using non invasive skin measurements. Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin. Attenuation coefficient (AC) is a measure of the decay of light intensity within the sample due to absorption and scattering.

Group	Value	95% CI
Baseline	4.145	± 0.765
Month 3 Follow Up	3.748	± 0.674
6 Month Follow Up	3.661	± 0.42

Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity) Secondary · Baseline, Month 3, Month 6

Skin laxity and elasticity will be assessed using non invasive skin measurements. Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin laxity, elasticity.

Laxity

Group	Value	95% CI
Baseline	1.772	± 0.751
Month 3 Follow-up	1.397	± 0.624
6 Month Follow Up	1.197	± 0.547

Elasticity

Group	Value	95% CI
Baseline	0.997	± 0.4
Month 3 Follow-up	1.053	± 0.356
6 Month Follow Up	0.808	± 0.387

Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) Secondary · Baseline, Month 3, Month 6

Skin Elastic, Viscoelastic and Ultimate Deformation will be assessed using non invasive skin measurements. Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin Elastic, Viscoelastic and Ultimate Deformation.

Elastic Deformation

Group	Value	95% CI
Baseline	3.317	± 4.227
Month 3 Follow-up	1.947	± 0.591
6 Month Follow Up	1.718	± 0.662

Viscoelastic Deformation

Group	Value	95% CI
Baseline	0.098	± 0.044
Month 3 Follow-up	0.091	± 0.047
6 Month Follow Up	0.087	± 0.043

Ultimate Deformation

Group	Value	95% CI
Baseline	2.316	± 0.819
Month 3 Follow-up	2.038	± 0.621
6 Month Follow Up	1.805	± 0.686

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148